Fast Track Designation Sample Clauses

Fast Track Designation. In addition to the foregoing, a separate process for Tier 3 designation shall operate during the second and third years of this Agreement. During the 2019-20 and 2020-21 academic years, Adjunct Faculty awarded Tier 2 status during the first year or second year of this Agreement who also have at least 10 years of service (with at least 5 years with an annual teaching load of more than 50%) with at least two class observations (at least one administrative) and 12 courses of student evaluations shall be eligible to apply for Tier 3 status.
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Fast Track Designation. In a November 4th press release, Lipocine shared its success in obtaining the FDA’s Fast Track Designation for LPCN 1144 for treatment of non-cirrhotic XXXX. The designation is requested by a sponsor company for drug can- didates that treat serious conditions and fill an unmet medical need. As no other XXXX treatments have been ap- proved and results from the LiFT trial were positive, the designation is welcome and not a surprise. The status should help Lipocine more efficiently design the Phase III program with closer guidance by the regulatory agency. It will also confer several benefits including more frequent interaction with the FDA, eligibility for accelerated approval, priority review and rolling review. Rolling review will allow Lipocine to submit portions of its new drug application (NDA) as they become ready rather than waiting until the entire package is ready thereby speeding the review pro- cess. Lipocine announced positive 12-week topline data from its LiFT study in January 2021. LiFT is a Phase II evalua- tion of its candidate LPCN 1144, an oral pro-drug of endogenous testosterone, in biopsy-confirmed, non-cirrhotic male XXXX patients with F1-F3 fibrosis. Results were positive and show statistical significance in the primary end- point of change in hepatic fat fraction, quantified via MRI-PDFF1 at week 12. Lipocine’s LPCN 1144 demonstrated robust, statistically significant efficacy in not only its primary endpoint of reduction of hepatic fat fraction, but also secondary endpoints that were published in August.

Related to Fast Track Designation

  • Series Designation The Series Designation establishing a Series may: (i) specify a name or names under which the business and affairs of such Series may be conducted; (ii) designate, fix and determine the relative rights, powers, authority, privileges, preferences, duties, responsibilities, liabilities and obligations in respect of Interests of such Series and the Members associated therewith (to the extent such terms differ from those set forth in this Agreement) and (iii) designate or authorize the designation of specific Officers to be associated with such Series. A Series Designation (or any resolution of the Managing Member amending any Series Designation) shall be effective when a duly executed original of the same is included by the Managing Member among the permanent records of the Company, and shall be annexed to, and constitute part of, this Agreement (it being understood and agreed that, upon such effective date, the Series described in such Series Designation shall be deemed to have been established and the Interests of such Series shall be deemed to have been authorized in accordance with the provisions thereof). The Series Designation establishing a Series may set forth specific provisions governing the rights of such Series against a Member associated with such Series who fails to comply with the applicable provisions of this Agreement (including, for the avoidance of doubt, the applicable provisions of such Series Designation). In the event of a conflict between the terms and conditions of this Agreement and a Series Designation, the terms and conditions of the Series Designation shall prevail.

  • Certificate of Designations The Certificate of Designations shall have been filed with the Secretary of State of the State of Delaware.

  • Preferred Stock Directors Whenever, at any time or times, dividends payable on the shares of Designated Preferred Stock have not been paid for an aggregate of six quarterly Dividend Periods or more, whether or not consecutive, the authorized number of directors of the Issuer shall automatically be increased by two and the holders of the Designated Preferred Stock shall have the right, with holders of shares of any one or more other classes or series of Voting Parity Stock outstanding at the time, voting together as a class, to elect two directors (hereinafter the “Preferred Directors” and each a “Preferred Director”) to fill such newly created directorships at the Issuer’s next annual meeting of stockholders (or at a special meeting called for that purpose prior to such next annual meeting) and at each subsequent annual meeting of stockholders until all accrued and unpaid dividends for all past Dividend Periods, including the latest completed Dividend Period (including, if applicable as provided in Section 3(a) above, dividends on such amount), on all outstanding shares of Designated Preferred Stock have been declared and paid in full at which time such right shall terminate with respect to the Designated Preferred Stock, except as herein or by law expressly provided, subject to revesting in the event of each and every subsequent default of the character above mentioned; provided that it shall be a qualification for election for any Preferred Director that the election of such Preferred Director shall not cause the Issuer to violate any corporate governance requirements of any securities exchange or other trading facility on which securities of the Issuer may then be listed or traded that listed or traded companies must have a majority of independent directors. Upon any termination of the right of the holders of shares of Designated Preferred Stock and Voting Parity Stock as a class to vote for directors as provided above, the Preferred Directors shall cease to be qualified as directors, the term of office of all Preferred Directors then in office shall terminate immediately and the authorized number of directors shall be reduced by the number of Preferred Directors elected pursuant hereto. Any Preferred Director may be removed at any time, with or without cause, and any vacancy created thereby may be filled, only by the affirmative vote of the holders a majority of the shares of Designated Preferred Stock at the time outstanding voting separately as a class together with the holders of shares of Voting Parity Stock, to the extent the voting rights of such holders described above are then exercisable. If the office of any Preferred Director becomes vacant for any reason other than removal from office as aforesaid, the remaining Preferred Director may choose a successor who shall hold office for the unexpired term in respect of which such vacancy occurred.

  • Restated Certificate The Company shall have filed the Restated Certificate with the Secretary of State of Delaware on or prior to the Closing, which shall continue to be in full force and effect as of the Closing.

  • Certificate of Incorporation The certificate of incorporation of the Company in effect at the Effective Time shall be the certificate of incorporation of the Surviving Corporation until amended in accordance with applicable law.

  • Charter Amendment The Company shall have filed the Charter Amendment with the Secretary of State of the State of Delaware, and such Charter Amendment shall be effective.

  • Preferred Stock Record Date Each person in whose name any certificate for a number of one one-thousandths of a share of Preferred Stock (or Common Stock and/or other securities, as the case may be) is issued upon the exercise of Rights shall for all purposes be deemed to have become the holder of record of such fractional shares of Preferred Stock (or Common Stock and/or other securities, as the case may be) represented thereby on, and such certificate shall be dated, the date upon which the Rights Certificate evidencing such Rights was duly surrendered and payment of the Purchase Price (and all applicable transfer taxes) was made; provided, however, that if the date of such surrender and payment is a date upon which the Preferred Stock (or Common Stock and/or other securities, as the case may be) transfer books of the Company are closed, such Person shall be deemed to have become the record holder of such shares (fractional or otherwise) on, and such certificate shall be dated, the next succeeding Business Day on which the Preferred Stock (or Common Stock and/or other securities, as the case may be) transfer books of the Company are open. Prior to the exercise of the Rights evidenced thereby, the holder of a Rights Certificate shall not be entitled to any rights of a stockholder of the Company with respect to shares for which the Rights shall be exercisable, including, without limitation, the right to vote, to receive dividends or other distributions or to exercise any preemptive rights, and shall not be entitled to receive any notice of any proceedings of the Company, except as provided herein.

  • Timber Designations Timber designated for cutting shall be confined to Sale Area, except as provided in B2.131, B2.14, B2.15, B2.32, and B5. 1. Sale Area Map

  • Filing of Certificate of Designation The Certificate of Designation shall have been filed with the Secretary of State of the State of Delaware.

  • The Certificate of Incorporation of the --------- Corporation shall not be amended in any manner which would materially alter or change the powers, preferences or special rights of the Series A Junior Participating Preferred Stock so as to affect them adversely without the affirmative vote of the holders of at least seventy-five percent of the outstanding shares of Series A Junior Participating Preferred Stock, voting together as a single class.

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